NeuroOne's OneRF Trigeminal Nerve Ablation System Shows Initial Success in Treating Facial Pain

NeuroOne Medical Technologies Corporation has successfully used its OneRF Trigeminal Nerve Ablation System to treat two patients with facial pain suffering from trigeminal neuralgia at University Hospitals in Cleveland, Ohio. The patients reported pain relief without postoperative complications, marking an important milestone for the company's expansion into pain management therapies. In August 2025, the company received 510(k) clearance from the U.S. Food and Drug Administration to market its OneRF Trigeminal Nerve Ablation System, which leverages the company's proprietary OneRF Ablation platform technology for the treatment of trigeminal neuralgia, a chronic pain condition affecting approximately 150,000 people in the United States annually according to the American Association of Neurological Surgeons (AANS) - April 2024.

Dr. Michael Staudt, the Lincoln Endowed Chair in Brain Health and an Associate Professor of Neurological Surgery at University Hospitals, performed radiofrequency ablations on two patients suffering from trigeminal neuralgia. The ablations were performed in the operating room and both patients reported pain relief, without complications. With NeuroOne's multi-contact probe, the surgeon was able to ablate the relevant nerve branches without repositioning the probe each time. Dr. Staudt commented that they are pleased with how NeuroOne's OneRF Trigeminal Nerve Ablation System performed ablations in these cases, and they look forward to adopting this tool in their clinical practice, believing it offers patients and physicians meaningful advantages over other systems available today.

The OneRF Trigeminal Nerve Ablation System features a minimally invasive surgical technology to treat severe, chronic facial pain. The system delivers targeted RF energy to ablate trigeminal nerve fibers, interrupting pain signaling. Differentiated features of this system include a first-of-its-kind multi-contact RF probe that allows for both precise localization and targeted ablation of the pain-conducting nerve tissue using the same RF probe and under temperature-controlled conditions, which enhances safety and accuracy. This system may also allow for reduced procedural time, as well as improved patient comfort and safety. Dave Rosa, CEO of NeuroOne, added that this is their first foray into pain management therapies with their thin film ablation technology, and importantly, this milestone successfully showcases their platform technology's unique ability to be adopted for both brain ablation procedures as well as pain management.

To that end, the company expects to pursue additional opportunities leveraging their technology platform in pain management and other therapeutic applications, including lower back pain, with an annual market of over $1 billion as they target a limited commercial launch. The successful cases at University Hospitals further validate NeuroOne's patented platform technology for both brain ablation and pain management procedures. The company markets a minimally invasive and high-definition/high-precision electrode technology platform with four FDA-cleared product families: Evo Cortical Electrodes, Evo sEEG Electrodes, OneRF Ablation System (for brain), and OneRF Trigeminal Nerve Ablation System. These solutions offer the potential to reduce the number of hospitalizations and surgical procedures, lower costs, and improve patient outcomes by offering combination diagnostic and therapeutic functions. For more information, visit https://www.nmtc1.com.